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Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Retiring Abroad with a Long-Term Care Insurance Policy

As more people consider retiring abroad, questions are arising about how an overseas retirement will affect long-term care insurance benefits. If you are planning to relocate out of the country and want to purchase or already...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

"Congressional Investigations Highlight Risks for Companies Across Industries"

An examination of congressional investigations in 2014 reminds us that such investigations can strike an industry or company at any time. Irrespective of the subjects, the investigations typically share one or more of the...more

California Physician Pleads Guilty to Failing to File FBAR for Bank Leumi Account

On February 2, 2015, Baruch Fogel, a California doctor, pleaded guilty in the U.S. District Court for the Central District of California to one count of willful failure to report the existence of a foreign bank account on a...more

Catching Up on the False Claims Act

From a corporate risk perspective, if your company is in the financial industry, healthcare, or defense industry, your greatest legal and compliance risk has to be the False Claims Act....more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Africa Update - October 2014 #5

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

Health Alert (Australia) - October 27, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 23 October 2014 - Vision Eye Institute Ltd v Kitchen & Anor [2014] QSC 260 In 2006, Kitchen sold...more

China Launches Pilot Program to Further Open Up Its Healthcare Industry

For a long period of time, China did not allow foreign investors to form wholly foreign-owned subsidiaries in China to operate medical institutions. This has now changed. ...more

China Update - September 2014 #2

In This Issue: - Doing Business in China - U.S-China Relations - Energy & Environmental - Food Safety - Health Care - Trade - Excerpt from Doing Business in China: The...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

JAMS Dispute Resolution Alert, Summer 2014

In This Issue: - Experts Predict ADR Will Help Resolve Affordable Care Act Claims - ADR News & Case Updates - Domestic Focus ..Supreme Court Ruling Expands Whistleblower Protections - Good...more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

China Cracking Down On Pharmaceutical Corruption

Stricter Blacklist Regime - On December 25, 2013, the National Health and Family Planning Commission of China (“National Health Commission”, former Ministry of Health) issued the amended Provisions Regarding the...more

Privacy and Security Becoming More Increasingly Critical

Privacy and security continue to be critical considerations for all businesses. While such considerations in the healthcare industry have received a lot of attention over the past years with the increasing requirements under...more

China Compliance Update: Commercial Bribery Risks Remain Very Real in China

The enactment of new legislation, as well as new and continuing investigations, demonstrates that Chinese regulators have not slowed down their efforts to ferret out corruption in the pharmaceutical sector and related...more

Healthcare Enforcement Actions and Trends: 2013 Overview

The Department of Justice (DOJ) and the Office of Inspector General for the U.S. Department of Health and Human Services continued aggressive enforcement of the healthcare industry in 2013. Officials employed a variety of...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more

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